批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
>>>原始批准或临时批准<<<
| 审批日期 | 提交号 | 审批结论 | 提交分类 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2012/04/11 |
ORIG-1（原始申请） |
Approval |
Not Applicable |
|
|
|
>>>补充申请<<<
| 审批日期 | 提交号 | 审批结论 | 补充类别或审批类型 | 审评优先级；罕用药状态 | 通知信、审评文件、说明书、包装标签 | 备注 |
|---|
| 2024/10/31 |
SUPPL-18（补充） |
Approval |
REMS - MODIFIED - D-N-A |
|
|
|
| 2024/01/03 |
SUPPL-16（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2024/01/03 |
SUPPL-15（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2021/03/04 |
SUPPL-14（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2019/10/11 |
SUPPL-13（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/20 |
SUPPL-12（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2018/09/18 |
SUPPL-11（补充） |
Approval |
REMS - PROPOSAL - D-N-A |
|
|
|
| 2017/06/01 |
SUPPL-7（补充） |
Approval |
Labeling-Medication Guide,Labeling-Package Insert |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-6（补充） |
Approval |
Labeling-Package Insert,Labeling-Medication Guide |
STANDARD
|
|
|
| 2016/12/16 |
SUPPL-5（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
| 2016/12/15 |
SUPPL-4（补充） |
Approval |
Labeling-Container/Carton Labels,Labeling-Package Insert |
STANDARD
|
|
|
| 2013/10/25 |
SUPPL-3（补充） |
Approval |
Labeling-Package Insert |
STANDARD
|
|
|
与本品相关的专利信息（来自FDA橙皮书Orange Book）
| 关联产品号 | 专利号 | 专利过期日 | 是否物质专利 | 是否产品专利 | 专利用途代码 | 撤销请求 | 提交日期 | 专利下载 | 备注 |
|---|
| 无 |
与本品治疗等效的药品
>>>活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:325MG;5MG; 治疗等效代码:AA<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040409 |
001 |
ANDA |
ANEXSIA 5/325 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
Yes |
AA |
2000/10/20
|
SPECGX LLC |
| 040655 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2006/01/19
|
STRIDES PHARMA INTL |
| 040736 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2006/08/25
|
AMNEAL PHARMS NY |
| 090118 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Discontinued |
No |
No |
AA |
2008/12/23
|
SUN PHARM INDS INC |
| 201013 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2012/04/11
|
AUROLIFE PHARMA LLC |
| 202214 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2013/03/27
|
TRIS PHARMA INC |
| 202991 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2016/04/12
|
RHODES PHARMS |
| 202935 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2016/06/15
|
STRIDES PHARMA INTL |
| 209037 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 210211 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2017/10/30
|
WES PHARMA INC |
| 203863 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2018/03/30
|
EPIC PHARMA LLC |
| 211487 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2018/11/07
|
ASCENT PHARMS INC |
| 209924 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2018/11/16
|
ELITE LABS INC |
| 211729 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Prescription |
No |
No |
AA |
2020/01/03
|
GRANULES |
| 214928 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;5MG |
Discontinued |
No |
No |
AA |
2021/12/30
|
PRINSTON INC |
>>>活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:325MG;7.5MG; 治疗等效代码:AA<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040405 |
001 |
ANDA |
ANEXSIA 7.5/325 |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
Yes |
AA |
2000/09/08
|
SPECGX LLC |
| 040432 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Discontinued |
No |
No |
AA |
2003/01/22
|
CHARTWELL |
| 040656 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2006/01/19
|
STRIDES PHARMA INTL |
| 090118 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Discontinued |
No |
No |
AA |
2008/12/23
|
SUN PHARM INDS INC |
| 201013 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2012/04/11
|
AUROLIFE PHARMA LLC |
| 202214 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2013/03/27
|
TRIS PHARMA INC |
| 202991 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2016/04/12
|
RHODES PHARMS |
| 040746 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2016/05/10
|
AMNEAL PHARMS NY |
| 202935 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2016/06/15
|
STRIDES PHARMA INTL |
| 209037 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 210211 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2017/10/30
|
WES PHARMA INC |
| 203863 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2018/03/30
|
EPIC PHARMA LLC |
| 211487 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2018/11/07
|
ASCENT PHARMS INC |
| 209924 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2018/11/16
|
ELITE LABS INC |
| 211729 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Prescription |
No |
No |
AA |
2020/01/03
|
GRANULES |
| 214928 |
002 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;7.5MG |
Discontinued |
No |
No |
AA |
2021/12/30
|
PRINSTON INC |
>>>活性成分:ACETAMINOPHEN; HYDROCODONE BITARTRATE; 剂型/给药途径:TABLET;ORAL; 规格:325MG;10MG; 治疗等效代码:AA<<<
| 申请号 | 产品号 | 申请类型 | 商品名 | 活性成分 | 剂型/给药途径 | 规格 | 市场状态 | RLD | RS | TE Code | 产品号批准日期 | 申请人 |
|---|
| 040355 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2000/05/31
|
STRIDES PHARMA INTL |
| 040400 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
Yes |
AA |
2000/07/26
|
SPECGX LLC |
| 040746 |
001 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2006/08/25
|
AMNEAL PHARMS NY |
| 090118 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Discontinued |
No |
No |
AA |
2008/12/23
|
SUN PHARM INDS INC |
| 201013 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2012/04/11
|
AUROLIFE PHARMA LLC |
| 202214 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2013/03/27
|
TRIS PHARMA INC |
| 202991 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2016/04/12
|
RHODES PHARMS |
| 202935 |
004 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2016/06/15
|
STRIDES PHARMA INTL |
| 209037 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2017/06/21
|
ABHAI LLC |
| 210211 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2017/10/30
|
WES PHARMA INC |
| 203863 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2018/03/30
|
EPIC PHARMA LLC |
| 211487 |
004 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2018/11/07
|
ASCENT PHARMS INC |
| 209924 |
004 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2018/11/16
|
ELITE LABS INC |
| 211729 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Prescription |
No |
No |
AA |
2020/01/03
|
GRANULES |
| 214928 |
003 |
ANDA |
HYDROCODONE BITARTRATE AND ACETAMINOPHEN |
ACETAMINOPHEN; HYDROCODONE BITARTRATE |
TABLET;ORAL |
325MG;10MG |
Discontinued |
No |
No |
AA |
2021/12/30
|
PRINSTON INC |